US9226992B2 - Implantable cartilaginous tissue repair device - Google Patents
Implantable cartilaginous tissue repair device Download PDFInfo
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- US9226992B2 US9226992B2 US12/063,966 US6396606A US9226992B2 US 9226992 B2 US9226992 B2 US 9226992B2 US 6396606 A US6396606 A US 6396606A US 9226992 B2 US9226992 B2 US 9226992B2
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- repair device
- hydrogel
- fibres
- silk
- tissue repair
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/38—Joints for elbows or knees
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
- A61F2002/3006—Properties of materials and coating materials
- A61F2002/30062—(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
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- A61F2002/30075—Properties of materials and coating materials swellable, e.g. when wetted
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2/30756—Cartilage endoprostheses
- A61F2002/30766—Scaffolds for cartilage ingrowth and regeneration
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- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2002/3092—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth having an open-celled or open-pored structure
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- A—HUMAN NECESSITIES
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2002/4495—Joints for the spine, e.g. vertebrae, spinal discs having a fabric structure, e.g. made from wires or fibres
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0061—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof swellable
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/06—Materials or treatment for tissue regeneration for cartilage reconstruction, e.g. meniscus
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29K2105/00—Condition, form or state of moulded material or of the material to be shaped
- B29K2105/04—Condition, form or state of moulded material or of the material to be shaped cellular or porous
- B29K2105/041—Microporous
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29K2105/00—Condition, form or state of moulded material or of the material to be shaped
- B29K2105/06—Condition, form or state of moulded material or of the material to be shaped containing reinforcements, fillers or inserts
- B29K2105/08—Condition, form or state of moulded material or of the material to be shaped containing reinforcements, fillers or inserts of continuous length, e.g. cords, rovings, mats, fabrics, strands or yarns
- B29K2105/0809—Fabrics
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29K2311/00—Use of natural products or their composites, not provided for in groups B29K2201/00 - B29K2309/00, as reinforcement
- B29K2311/10—Natural fibres, e.g. wool or cotton
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Dermatology (AREA)
- Biomedical Technology (AREA)
- Composite Materials (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Mechanical Engineering (AREA)
- Dispersion Chemistry (AREA)
- Neurology (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Materials Engineering (AREA)
- Textile Engineering (AREA)
- Rheumatology (AREA)
- Inorganic Chemistry (AREA)
- Prostheses (AREA)
- Materials For Medical Uses (AREA)
Abstract
Description
- 1. Prepare a circa 20 w/v % solution of degummed Bombyx mori silk by dissolving 20 g/100 ml 9.3M LiBr solution at 60 degrees C. for 4 hours with continuous stirring. Transfer to a weighed dialysis tube (preferably MWCO 3500 or smaller). Dialyse against 5 changes of deionised water for 2 days at 4 degrees C. The resulting solution should be about 8% w/v. Partially dry within the dialysis bag in a vacuum desiccator until the desired protein concentration (between 8-15% w/v) has been reached as assessed by refractometry or by gravimetry after drying samples to constant weight in a vacuum oven heated to 50 degrees C. Gently squeeze contents of dialysis tube down and reclip bag so that the protein solution completely fills the clipped off length of tubing.
- 2. Dialyse samples against 0.5-1% acetic acid for not longer than 12 hours at 4 degrees C.
- 3. Alternatively treat small drops of concentrated fibroin solution with vapour from 0.1% acetic acid or add 10 μl of 1 M sodium citrate buffer (pH 5.0) to 1 ml of concentrated fibroin and immediately transfer to a cylindrical mould before leaving for 12 hours to gel.
- 4. Freeze at −50 degrees C. for 20 minutes.
- 5. The material is sufficiently stiff (compressive modulus about 1 MPa at optimal protein concentrations) to give good hand sections which can be mounted in water and observed by polarizing or differential interference microscopy to determine pore size distribution and density of interconnecting pores. Material should also be subjected to critical point drying and examined with a SEM.
- 6. The intercommunication of pores may be rapidly assessed by squeezing of the wet gel between thumb and forefinger. A high level of intercommunication of the pores is indicated by rapid outflow of water followed by an inflow of air into all parts of the gel on relaxing pressure.
PROTOCOL B: Preparation of Meniscal Repair Device. - 1. A cylindrical Lucite former with a diameter equal to that of the internal diameter of the crescent-shaped meniscal repair device is to be used. A sausage-shaped core of approximately randomly orientated wild silk fibres is infiltrated with fresh 8-12% w/v silk fibroin solution prepared as described in Protocol A. The fibroin is gelled by immersion of the core in dilute sodium citrate buffer at pH 4.5. Pieces of degummed wild silk cloth with a loose weave are cut to an appropriate approximately kidney shape and coated with fibroin solution. Layers are added successively to build up the crescent shape of the device. Each layer is stitched to the one beneath with braided wild silk suture with throws to mimic the circumferential fibres of the device. Some radial stitches are also made. The radial width of the silk pieces is reduced to produce the wedge shaped profile of the device. A peripheral flange and medial ligament analogue is also included and stitched at appropriate stages while building up the body of the device.
- 2. The windings on the opposite side of the former to the body of the device are cut and the whole structure removed from the former.
- 3. The fibroin matrix is gelled as described in protocol C below by immersing the whole device in 0.1-1.5 M sodium phosphate solution buffered to pH 6.3 at 4 degrees C. for between 4-16 hours. Alternatively fibroin matrix within the device can be gelled by immersion in 0.1-1% acetic acid for 12 hours or by exposure to vapour from 0.1% w/v acetic acid—in both instances for 12 hours at 4 degrees C.
- 4. The matrix was frozen rapidly at −50 degrees C. to generate a porous architecture.
- 5. The structure is hardened by transferring it to 50% ethanol and stored in this solution or cross-linked in 10-25% glutaraldehyde, exhaustively washed and reduced in aqueous 0.1% sodium borohydride until no more hydrogen is evolved.
- 6. The resulting composite is remarkably stiff and strong and has an open porous architecture.
PROTOCOL C: Production of Mineralised Silk Proteins - 1. 0.1-1.5M phosphate solutions are prepared using sodium dihydrogen phosphate. 1 g of 0.08M Trizma base is added per 100 ml of phosphate solution and the pH is adjusted with drops of 10 to 1M HCl to give a range of pH values between 6.3-9.0.
- 2. Dialysis bags containing 10% w/v fibroin solution are prepared as in protocol A. The bags are then placed in one of the Tris buffered phosphate solutions prepared in
step 1 and kept at 4 degrees C. for between 4-16 hours to gel the silk protein and introduce phosphate ions. - 3. The dialysis bags containing the fibroin are rapidly frozen at −20 degrees C. to introduce a porous structure and then thawed at room temperature. The freeze-thaw cycle may be repeated up to 5 times to increase the interconnectivity of the pores.
- 4. Thawed gels are removed from the dialysis tubing and, for most applications, the impermeable surface layer of the gels is removed using a sharp scalpel. The silk gels are then cut into cubes for further treatments.
- 5. The cubes of gel are freeze-dried and then transferred to 0.25-2.5M calcium chloride solutions buffered to pH 7.0-9.0 with Tris HCl as in
step 1. The pieces of gel are left for 24 hours at 37 degrees C. in this solution. Alternatively, the cubes of gel may be transferred directly to a buffered calcium chloride solution without freeze drying or may be air dried at 20 degrees C. before transfer to the buffered calcium chloride solution. - 6. Silk fibre lays incorporating gelled fibroin prepared as described in protocol B can be mineralized using the same procedure with or without enclosing them in dialysis membrane.
Claims (20)
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GBGB0516846.3A GB0516846D0 (en) | 2005-08-17 | 2005-08-17 | Meniscal repair device |
GB0516846.3 | 2005-08-17 | ||
PCT/GB2006/003079 WO2007020449A2 (en) | 2005-08-17 | 2006-08-17 | Implantable cartilaginous tissue repair device |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/GB2006/003079 A-371-Of-International WO2007020449A2 (en) | 2005-08-17 | 2006-08-17 | Implantable cartilaginous tissue repair device |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US14/955,081 Division US20160228604A1 (en) | 2005-08-17 | 2015-12-01 | Method for the manufacture of an implantable cartilaginous tissue repair device |
Publications (2)
Publication Number | Publication Date |
---|---|
US20090171467A1 US20090171467A1 (en) | 2009-07-02 |
US9226992B2 true US9226992B2 (en) | 2016-01-05 |
Family
ID=35098436
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US12/063,966 Expired - Fee Related US9226992B2 (en) | 2005-08-17 | 2006-08-17 | Implantable cartilaginous tissue repair device |
US14/955,081 Abandoned US20160228604A1 (en) | 2005-08-17 | 2015-12-01 | Method for the manufacture of an implantable cartilaginous tissue repair device |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US14/955,081 Abandoned US20160228604A1 (en) | 2005-08-17 | 2015-12-01 | Method for the manufacture of an implantable cartilaginous tissue repair device |
Country Status (7)
Country | Link |
---|---|
US (2) | US9226992B2 (en) |
EP (1) | EP1948256B1 (en) |
JP (1) | JP5758063B2 (en) |
CN (1) | CN101291694B (en) |
CA (1) | CA2619693C (en) |
GB (1) | GB0516846D0 (en) |
WO (1) | WO2007020449A2 (en) |
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Also Published As
Publication number | Publication date |
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US20160228604A1 (en) | 2016-08-11 |
US20090171467A1 (en) | 2009-07-02 |
CA2619693C (en) | 2014-10-07 |
CN101291694A (en) | 2008-10-22 |
CA2619693A1 (en) | 2007-02-22 |
JP5758063B2 (en) | 2015-08-05 |
WO2007020449A2 (en) | 2007-02-22 |
GB0516846D0 (en) | 2005-09-21 |
EP1948256B1 (en) | 2017-07-05 |
CN101291694B (en) | 2015-11-25 |
WO2007020449A3 (en) | 2007-05-24 |
EP1948256A2 (en) | 2008-07-30 |
JP2009508540A (en) | 2009-03-05 |
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